Mechanisms of Mindfulness and Stress Resilience: A Mobile App Mindfulness Training Study
Primary Purpose
Psychological Stress, Mindfulness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Training
Mindful Attention Only Training
Analytic Thinking Training
Sponsored by
About this trial
This is an interventional basic science trial for Psychological Stress focused on measuring mindfulness, psychological stress, immune marker, wellness programs, mobile applications, cortisol
Eligibility Criteria
Inclusion Criteria:
- English speaking
- Moderate- to high-stress (4-item Perceived Stress Scale score of 6 or higher)
Exclusion Criteria:
- Diagnosis of chronic mental (e.g., recurrent depression, schizophrenia, personality disorder) or physical disease (e.g., cancer, HIV, heart disease, diabetes, bleeding disorder)
- Hospitalization in past 3 months
- Medication use that interferes with HPA-axis activity (e.g., corticosteroids)
- Current oral contraceptive use
- Current antibiotic, antiviral, or antimicrobial treatment
- Travel outside the country within the past 6 months to any country on the CDC travel alert list
- Recreational drug use, excessive alcohol or tobacco use
- Significant experience with or daily practice of mindfulness meditation or related mind-body practice
Sites / Locations
- Carnegie Mellon University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Mindfulness Training
Mindful Attention Only Training
Analytic Thinking Training
Arm Description
14-lesson audio-guided mindfulness training program instructing present-moment attention and an orientation of acceptance
14-lesson audio-guided mindfulness training program instructing present-moment attention only
14-lesson audio-guided analytic thinking program encouraging reflection on one's thoughts, feelings, and behaviors, but not instructing mindfulness
Outcomes
Primary Outcome Measures
Daily life stress assessed via Ecological Momentary Assessment
Inflammatory Biomarkers assessed via Dried Blood Spot
Five Dried Blood Spot samples are obtained from participants' finger for assessment of circulating markers of inflammation (CRP, IL-6).
Secondary Outcome Measures
Daily life state attention and acceptance assessed via Ecological Momentary Assessment
Subjective stress in response to social evaluative threat (TSST)
Salivary Cortisol AUC in response to social evaluative threat (TSST)
Blood Pressure reactivity to social evaluative threat (TSST)
Evening salivary cortisol
Sustained attention measured by the Dichotic Listening Task
Full Information
NCT ID
NCT02433431
First Posted
April 23, 2015
Last Updated
May 13, 2016
Sponsor
Carnegie Mellon University
Collaborators
Mind and Life Institute, Hadley, Massachusetts, Yoga Science Foundation, Penn State University, University of Pittsburgh, Virginia Commonwealth University, 01 Expert Systems, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02433431
Brief Title
Mechanisms of Mindfulness and Stress Resilience: A Mobile App Mindfulness Training Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Carnegie Mellon University
Collaborators
Mind and Life Institute, Hadley, Massachusetts, Yoga Science Foundation, Penn State University, University of Pittsburgh, Virginia Commonwealth University, 01 Expert Systems, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test the active components of mindfulness meditation for reducing psychological stress and improving biomarkers of health. This study compares the effects of three brief trainings: (1) training in both present-moment attention and mindful acceptance, (2) training in present-focused attention, and (3) an active psychological training with no mindfulness content.
Detailed Description
Mindfulness meditation practices are widely used among the general public, with people seeking to reduce stress, pain, inflammation, depression, and disease symptoms. Moreover, randomized controlled trials have shown mindfulness training programs to be effective in improving a broad range of psychological and physical health outcomes, particularly among populations with high stress burdens. Still, little is known about the mechanisms underlying mindfulness training that drive these effects. This study tests the active components of mindfulness that impact stress responding and health biomarkers.
The study separates attention and acceptance mindfulness instructions into three 14-day training programs delivered to a stressed adult population: (1) attention and acceptance instructions, (2) attentional monitoring instructions only, or (3) analytic thinking with no mindfulness instruction. Intervention programs are delivered on participants' own smartphones, providing a platform for maximal experimental control in testing the active ingredients of mindfulness training.
Participants are recruited from the Pittsburgh community. At a baseline laboratory session, they complete psychosocial questionnaires and tasks and provide a dried blood spot sample. On their own, they complete pre- and post-intervention Ecological Momentary Assessment measures of stress, attention, and acceptance in daily life. Between these assessments, participants have 14 days to complete their randomly assigned 14-lesson intervention program. Participants return to the lab for post-intervention assessments (questionnaires, tasks, dried blood sample), listen to a final training session from their intervention program, and complete the Trier Social Stress Test. Participants are compensated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Mindfulness
Keywords
mindfulness, psychological stress, immune marker, wellness programs, mobile applications, cortisol
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Training
Arm Type
Active Comparator
Arm Description
14-lesson audio-guided mindfulness training program instructing present-moment attention and an orientation of acceptance
Arm Title
Mindful Attention Only Training
Arm Type
Active Comparator
Arm Description
14-lesson audio-guided mindfulness training program instructing present-moment attention only
Arm Title
Analytic Thinking Training
Arm Type
Active Comparator
Arm Description
14-lesson audio-guided analytic thinking program encouraging reflection on one's thoughts, feelings, and behaviors, but not instructing mindfulness
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training
Intervention Description
Mindfulness training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Attention Only Training
Intervention Description
Mindful attention training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.
Intervention Type
Behavioral
Intervention Name(s)
Analytic Thinking Training
Intervention Description
Comparison analytic thinking intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.
Primary Outcome Measure Information:
Title
Daily life stress assessed via Ecological Momentary Assessment
Time Frame
change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
Title
Inflammatory Biomarkers assessed via Dried Blood Spot
Description
Five Dried Blood Spot samples are obtained from participants' finger for assessment of circulating markers of inflammation (CRP, IL-6).
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Secondary Outcome Measure Information:
Title
Daily life state attention and acceptance assessed via Ecological Momentary Assessment
Time Frame
change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
Title
Subjective stress in response to social evaluative threat (TSST)
Time Frame
assessed at post-intervention, which is an average of 3.5 weeks
Title
Salivary Cortisol AUC in response to social evaluative threat (TSST)
Time Frame
assessed at post-intervention, which is an average of 3.5 weeks, at time 0, and 25, 35, and 60 minutes post-TSST
Title
Blood Pressure reactivity to social evaluative threat (TSST)
Time Frame
assessed at post-intervention, which is an average of 3.5 weeks, at 2-minute intervals during session
Title
Evening salivary cortisol
Time Frame
change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
Title
Sustained attention measured by the Dichotic Listening Task
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Other Pre-specified Outcome Measures:
Title
Daily life affect assessed via Ecological Momentary Assessment
Time Frame
change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
Title
Daily life social interactions assessed via Ecological Momentary Assessment
Time Frame
change from baseline 3-day period to post-intervention 3-day period, which is an average of 2.5 weeks
Title
Perceived stress measured by the PSS
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Mindfulness facets measured by the FFMQ-sf
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Mindfulness measured by the PHLMS
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Attentional control measured by the ACS
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Nonattachment measured by Nonattachment Scale
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Subjective health measured by the SF-12
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Sleep quality measured by the PSQI-sf
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Loneliness measured by the UCLA Loneliness Scale
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Interpersonal support measured by the ISEL-12
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Social network measured by the SNI
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Depression measured by the CES-D-10
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Mind-wandering measured by the RRQ
Time Frame
change from baseline to post-intervention, which is an average of 3.5 weeks
Title
Treatment expectancies measured by Credibility/Expectancy Questionnaire
Time Frame
post-intervention, which is an average of 3.5 weeks
Title
Alerting, orienting, and executive control measured by the ANT task
Time Frame
post-intervention, which is an average of 3.5 weeks
Title
Subjective responses to the training program intervention
Time Frame
composite of ratings made after each of 14 intervention lessons, an average of 2 weeks following baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English speaking
Moderate- to high-stress (4-item Perceived Stress Scale score of 6 or higher)
Exclusion Criteria:
Diagnosis of chronic mental (e.g., recurrent depression, schizophrenia, personality disorder) or physical disease (e.g., cancer, HIV, heart disease, diabetes, bleeding disorder)
Hospitalization in past 3 months
Medication use that interferes with HPA-axis activity (e.g., corticosteroids)
Current oral contraceptive use
Current antibiotic, antiviral, or antimicrobial treatment
Travel outside the country within the past 6 months to any country on the CDC travel alert list
Recreational drug use, excessive alcohol or tobacco use
Significant experience with or daily practice of mindfulness meditation or related mind-body practice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily K Lindsay, MS
Organizational Affiliation
Carnegie Mellon University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. David Creswell, PhD
Organizational Affiliation
Carnegie Mellon University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carnegie Mellon University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30550321
Citation
Lindsay EK, Chin B, Greco CM, Young S, Brown KW, Wright AGC, Smyth JM, Burkett D, Creswell JD. How mindfulness training promotes positive emotions: Dismantling acceptance skills training in two randomized controlled trials. J Pers Soc Psychol. 2018 Dec;115(6):944-973. doi: 10.1037/pspa0000134.
Results Reference
derived
Learn more about this trial
Mechanisms of Mindfulness and Stress Resilience: A Mobile App Mindfulness Training Study
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